Fuji Yakuhin Co., Ltd.
Form 483 issued November 26, 2019 · Toyama, Japan
- Inspection
- Nov 18 – Nov 26, 2019
- Investigator
- Darren S. Brown
- Observations
- 4
- Pages
- 3
- FEI number
- 3008538640
In short: On November 26, 2019, FDA issued a Form 483 with 4 observations to Fuji Yakuhin Co., Ltd. in Toyama, Toyama (FEI 3008538640) after an inspection that ran Nov 18 – Nov 26, 2019. The investigator was Darren S. Brown. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Electronic records are used, but they do not meet retention requirements to ensure that they are…
- 04
Certificates of testing of containers and closures are accepted in lieu of testing without establishing the…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmFuji Yakuhin Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Fuji Yakuhin Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Fuji Yakuhin Co., Ltd.?
Darren S. Brown is named on this Form 483, for the inspection of Nov 18 – Nov 26, 2019. Each investigator has a profile showing what they cite most.
When was Fuji Yakuhin Co., Ltd. inspected by FDA?
The inspection ran Nov 18 – Nov 26, 2019, and the Form 483 is dated November 26, 2019.
How do I get the full Form 483 for Fuji Yakuhin Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.